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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-023950-35 | EudraCT Number |
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The objective of this study is to determine the biologic activity of a Poa pratensis allergen extract in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).
This is an open, unblinded and non-randomized biological assay. The study design is a slight modification of the recommendations proposed by the Nordic Guidelines.
Four concentrations of Poa pratensis allergen extract, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Poa pratensis allergen extract at 4 different concentrations. Positive control. Negative control. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Four different concentrations of Poa pratensis allergen extract, positive control and negative control | Biological | Four concentrations of Poa pratensis allergen extract, together with a positive and negative control will be tested in every patient in duplicate on the volar surface of the forearm. |
| Measure | Description | Time Frame |
|---|---|---|
| Wheal size area (mm2) on the skin at the site of the puncture during the immediate phase. | Test sites should be inspected and recorded 15-20 min after application |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| María José Gómez | Laboratorios LETI, S.L.Unipersonal | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| C.E. Virgen de la Cinta - Hospital Juan Ramón Jiménez | Huelva | Andalusia | 21003 | Spain | ||
| Hospital Universitario Marqués de Valdecilla |
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|
| Santander |
| Cantabria |
| 39008 |
| Spain |